510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K923512Substantially Equivalent

Operating Room Needle Counter

Sharp-Trap, Inc., Southfield MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923512 is the FDA 510(k) clearance record for OPERATING ROOM NEEDLE COUNTER, a class II device, cleared for Sharp-Trap, Inc. on under FDA product code MMK (Container, Sharps). FDA records list one 510(k) clearance for Sharp-Trap, Inc. As of , FDA records show no recalls naming K923512.

Clearance record

Decision date
Received
(139 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Sharp-Trap, Inc. 15777 W. 10 Mile #200-100, Southfield MI
510(k) summary
Statement
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260